Declaration of Incorporation or CE Declaration of Conformity? The Difference Explained
Declaration of Incorporation or CE Declaration of Conformity? The Difference Explained
Not every component built into an industrial plant receives a CE mark. Whether a CE mark with a declaration of conformity is required, or instead a declaration of incorporation, depends on a single distinction: complete versus partly completed machinery.
Complete vs. Partly Completed Machinery
Under the Machinery Directive 2006/42/EC, a partly completed machine is an assembly which almost constitutes a machine but cannot in itself perform a specific application. It is solely intended to be incorporated into or assembled with other machinery.
Typical examples from practice:
Industrial robots (without a specific application)
Drive systems
Combustion engines
High-voltage electric motors
A plant with a missing safety guard
A machine without a control system
Only complete machines receive a CE mark and a CE declaration of conformity. Partly completed machines instead receive only a declaration of incorporation – and no CE mark.
The Manufacturer's Obligations for Partly Completed Machinery
Under Article 13 of the Machinery Directive, the manufacturer of a partly completed machine must ensure, before placing it on the market, that three things are in place:
the relevant special technical documentation (Annex VII Part B)
assembly instructions (Annex VI)
a declaration of incorporation (Annex II Part 1 Section B)
The assembly instructions and declaration of incorporation remain attached to the partly completed machine until it is incorporated – after which they automatically become part of the technical documentation of the finished, complete machine.
Why a Declaration of Incorporation Requires More Than a Plain Declaration of Conformity
Since the partly completed machine is not yet CE-compliant, the declaration of incorporation goes further in content than a plain CE declaration of conformity: it must provide the operator or the person placing the machine on the market with more information – specifically, what the manufacturer of the partly completed machine has already assessed with regard to safety and health requirements. On this basis, the plant builder must later be able to declare the CE conformity of the overall system once the partly completed machine has been incorporated.
Free Movement of Goods Despite No CE Mark
A partly completed machine may nevertheless be placed on the market throughout the EU without restriction (Article 6 of the Machinery Directive) – provided that:
the manufacturer's declaration of incorporation clearly states that the machine is intended to be assembled with another machine, and
the declaration of incorporation is drawn up in accordance with Annex II Part 1 Section B.
The Declaration of Conformity at a Glance
At the end of the conformity procedure for a complete machine stands the CE declaration of conformity. It confirms in writing that the product meets all relevant requirements and must include, among other things: identification of the manufacturer, description of the product, the directives applied, and the standards complied with. It must be retained and made available to the authorities upon request.
Free Templates to Download
To help you get started, editable Word templates are available as a free download. Currently available in German.
For the complete procedure – including the conformity assessment of the finished overall machine after incorporation and all detailed requirements from the annexes of the Machinery Directive – the e-book "CE Marking in Plant Engineering" provides a step-by-step guide.
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